A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children With Myopia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 342
- 试验地点
- 2
- 主要终点
- myopia progression
研究概览
简要总结
This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be accompanied by a parent or guardian who is able to read and comprehend Chinese/English and sign a record of informed consent/assent; at baseline, be within the age range of 7 to 13 years old inclusive; be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D); astigmatism ≤1.50D; anisometropia of not more than 1.50D; be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; have ocular findings deemed to be normal; vision correctable to at least 0.8 or better in each eye with spectacles.
排除标准
- •Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- •Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial.
- •History of eye trauma Amblyopia Strabismus History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial.
- •Known allergy or intolerance to ingredients to cycloplegic eye-drops. Currently enrolled in another clinical trial.
研究组 & 干预措施
Group A
single vision lens
干预措施: spectacle lens (Other)
Group A
single vision lens
干预措施: single vision lens (Other)
Group B
one of ZEISS BD spectacle lens designs 1 to 5
干预措施: spectacle lens (Other)
Group C
one of ZEISS BD spectacle lens designs 1 to 5
干预措施: spectacle lens (Other)
Group D
one of ZEISS BD spectacle lens designs 1 to 5
干预措施: spectacle lens (Other)
Group E
one of ZEISS BD spectacle lens designs 1 to 5
干预措施: spectacle lens (Other)
Group F
one of ZEISS BD spectacle lens designs 1 to 5
干预措施: spectacle lens (Other)
结局指标
主要结局
myopia progression
时间窗: 12 monthly
change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group
次要结局
- axial elongation(12 monthly)
- Subjective responses and compliance(12 monthly)